The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Model 3888 Pisces-quad Plus Lead.
Device ID | K923567 |
510k Number | K923567 |
Device Name: | MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD |
Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
Contact | David H Mueller |
Correspondent | David H Mueller MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
Product Code | GZB |
CFR Regulation Number | 882.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-17 |
Decision Date | 1992-11-05 |